A Research Study to Compare a New Weekly Insulin Insulin Icodec Used With DoseGuide App and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before

  • STATUS
    Recruiting
  • End date
    Jul 25, 2022
  • participants needed
    1096
  • sponsor
    Novo Nordisk A/S
Updated on 1 August 2021

Summary

This study compares insulin icodec to different daily insulins in people with type 2 diabetes.

The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App.

The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Details
Condition NIDDM, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment insulin degludec, Insulin Icodec, Insulin Glargine 100U/mL, Insulin Glargine 300U/mL
Clinical Study IdentifierNCT04760626
SponsorNovo Nordisk A/S
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female
Age above or equal to 18 years at the time of signing informed consent
Diagnosed with T2D greater than or equal to 180 days prior to the day of screening
HbA1c above 7.0% (53 mmol/mol) as measured by central lab
Insulin nave. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists
Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator

Exclusion Criteria

Known or suspected hypersensitivity to trial product(s) or related products
Previous participation in this trial. Participation is defined as signed informed consent
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)
Any disorder which in the investigator's opinion might jeopardise subject's safety
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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